A Study of Selinexor Monotherapy in Subjects With JAK Inhibitor-naïve Myelofibrosis and Moderate Thrombocytopenia
Karyopharm Therapeutics Inc · NCT05980806
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 2
- Target enrollment
- 58
- US sites recruiting
- 7
- Study start
- April 22, 2024
- Record last updated
- February 12, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
The main purpose of this study is to evaluate the efficacy of selinexor in JAKi-naïve participants with myelofibrosis (MF) and with normal platelet counts or with mild to moderate thrombocytopenia based on spleen volume reduction (SVR). Additional efficacy and safety parameters will also be assessed during the study.
Being studied: Selinexor 60 mg; Selinexor 40 mg; Ruxolitinib; Pacritinib; Momelotinib
Conditions: Myelofibrosis; Moderate Thrombocytopenia; Mild Thrombocytopenia
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Key Inclusion Criteria
- A diagnosis of MF or post-ET or post-PV MF according to the 2016 World Health Organization (WHO) classification of MPN, confirmed by the most recent local pathology report
- Measurable splenomegaly during the screening period as demonstrated by spleen volume of greater than or equal to (>=) 450 cubic square centimeter (cm\^3) by MRI or CT scan (results from MRI or CT imaging performed within 28 days prior to C1D1 are acceptable)
- DIPSS risk category of intermediate-1 with symptoms, or intermediate-2, or high-risk
- ECOG Performance Status less than or equal to (\<=) 2
- Platelet count of greater than or equal to (>=) 50 x 10\^9/L without platelet transfusion within 7 days prior to the first dose of selinexor
- Absolute neutrophil count (ANC) >=1.0 × 10\^9/L without need for growth factors within 7 days prior to the first dose of selinexor
- Adequate liver function as defined by the following: aspartate transaminase (AST) and alanine transaminase (ALT) \<= 2.5 × upper limit normal (ULN) and serum total bilirubin \<= 3×ULN
- Calculated creatinine clearance (CrCl) greater than (>) 15 milliliter per minute (mL/min) based on the Cockcroft and Gault formula
- Active symptoms of MF as determined by presence of at least 2 symptoms with an average score >= 5 or total score of >= 12 at screening (at least 5 of 7 consecutive days immediately preceding C1D1) using the MFSAF V4.0
- Must provide bone marrow biopsy samples (samples obtained up to 3 months prior to C1D1 are permitted) at screening and during the study
- Currently not eligible for stem cell transplantation
- Must be willing to complete the MFSAF V4.0 daily during the study for evaluating the symptom response (i.e., TSS50)
Key Exclusion Criteria
- More than 10% blasts in peripheral blood or bone marrow (accelerated or blast phase)
- Previous treatment with JAK inhibitors for MF
- Previous treatment with selinexor or other XPO1 inhibitors
- Females who are pregnant or lactating
- Prior splenectomy, splenic radiation, or a splenic embolization within 6 months prior to C1D1
- History of myocardial infarction, unstable angina, percutaneous transluminal coronary angioplasty (PTCA), coronary artery bypass graft (CABG), cerebrovascular accident (transient ischemic attack [TIA]), ventricular arrhythmias, congestive heart failure class > 2 per New York Heart Association (NYHA) within 6 months of C1D1
- Unable to tolerate two forms of antiemetics prior to each dose for the first two cycles
Recruiting US locations
City of Hope - Duarte Main Site
Duarte, CA 91010
Site contact: Haris Ali · 6263564673 · harisali@coh.org
Maryland Oncology Hematology - Independent of SCRI/ US Oncology
Columbia, MD 21044
Site contact: Mohit Narang · 304-942-9220 · mohit.narang@usoncology.com
Weill Cornell Medicine NewYork-Presbyterian
New York, NY 10021
Site contact: Ellen Ritche · 646-962-4580 · ritchie@med.cornell.edu
Duke University
Durham, NC 27705
Site contact: Lindsay Rein · 919-684-8964 · lindsay.magura@duke.edu
Cleveland Clinic
Cleveland, OH 44195
Site contact: Aaron Gerds · 216-445-9840 · gerdsa@ccf.org
MD Anderson
Houston, TX 77030
Site contact: Prithviraj Bose · (713) 792-7747 · PBose@mdanderson.org
Huntsman Cancer Institute
Salt Lake City, UT 84112
Site contact: Srinivas Tantravahi · 801-213-6170 · Srinivas.Tantravahi@hci.utah.edu
Study contacts (from the official record)
- Karyopharm Medical Information · (888) 209-9326 · clinicaltrials@karyopharm.com